At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,293 enrolled
Drug / intervention
Budesonide/formoterol (Symbicort Turbuhaler) +1 moredrug
Likely dose
Budesonide/formoterol (Symbicort Turbuhaler) 4.5 microgramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating Budesonide/formoterol (Symbicort Turbuhaler) and Formoterol (Oxis Turbuhaler) for Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,293 participants across 119 sites in 9 countries.
Detailed Summary
The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesIndia, Japan, Philippines, Poland, Russia, South Korea, Taiwan, Ukraine, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
First PostedFeb 2010
Primary CompletionMar 2011
TodayJul 2026
First PostedFeb 17, 2010
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.4 years ago
Interventions
Budesonide/formoterol (Symbicort Turbuhaler)drug
2x160/4.5 microgram, inhalation, twice daily, 12 weeks
Formoterol (Oxis Turbuhaler)drug
2 X 4.5 microgram, inhalation, twice daily, 12 weeks